Closed loop control with reference measurement and methods thereof

• US 9,943,644 B2
• Filed: 08/31/2008
• Issued: 04/17/2018
• Est. Priority Date: 08/31/2008
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hayter, Gary
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US12/202,302
• Publication Number:
  US 20100057041A1
• Time in Patent Office: 3,516 Days
• Field of Search: 604131, 604 65, 604 66
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Methods, system and devices for monitoring a plurality of parameters associated with a closed loop control operation including continuously monitoring a physiological condition and automatic administration of a medication, detecting an impending administration of the medication level exceeding a predetermined threshold level, retrieving one or more signals associated with the monitored physiological condition, determining an accuracy indication of the retrieved one or more signals associated with the monitored physiological condition, and executing the administration of the medication level based on the accuracy indication are provided.

Claims

1. A method, comprising:

monitoring a plurality of parameters associated with a closed loop control operation including continuously monitoring a physiological condition and an automatic administration of insulin;

detecting an impending administration of the insulin exceeding a predetermined insulin dose threshold level;

retrieving one or more signals associated with the monitored physiological condition in response to detecting that the impending administration of the insulin exceeds the predetermined insulin dose threshold level;

determining an accuracy indication of the retrieved one or more signals associated with the monitored physiological condition, the accuracy indication associated with a false low glucose reading and based on a signal dropout condition or an early signal attenuation condition;

automatically adjusting execution of the impending administration of the insulin to a predetermined insulin dose safety level when the determined accuracy indication of the retrieved one or more signals associated with the monitored physiological condition exceeds a predetermined accuracy threshold level; and

discontinuing retrieving the one or more signals associated with the monitored physiological condition in response to detecting that the impending administration of the insulin exceeds the predetermined insulin dose threshold level when a predetermined consecutive number of the retrieved one or more signals associated with the monitored physiological condition are within the predetermined accuracy threshold;

wherein the adjustment to the execution of the impending administration of the insulin to the predetermined insulin dose safety level is made, and receipt of the one or more signals associated with the monitored physiological condition are discontinued, upon determining the accuracy indication is associated with a false low glucose reading and is based on a signal dropout condition or an early signal attenuation condition.

2. The method of claim 1, wherein the accuracy indication determination includes:

determining the retrieved one or more signals associated with the monitored physiological condition outside of a predetermined accuracy acceptable range; and

generating a request command to enter a current blood glucose value.

3. The method of claim 1, wherein the monitored physiological condition is associated with a glycemic level of a patient.

4. The method of claim 1, wherein the continuously monitored physiological condition includes analyte levels.

5. The method of claim 1, wherein when the accuracy indication indicates an unacceptable level of accuracy associated with the retrieved one or more signals, modifying the closed loop control operation to perform one or more of requesting an additional blood glucose measurement value, disabling the closed loop control operation and initiating a semi-closed loop control or manual control operation, or performing recalibration of the retrieved one or more signals.

6. The method of claim 1, wherein determining the accuracy indication includes:

receiving a blood glucose measurement; and

analyzing the retrieved one or more signals associated with the monitored physiological condition based on the received blood glucose measurement.

7. The method of claim 6, wherein analyzing the retrieved one or more signals includes calibrating the one or more signals with the received blood glucose measurement.

8. The method of claim 1, further comprising detecting an adverse condition associated with at least one of the monitored plurality of parameters and determining a severity level of the detected adverse condition based, at least in part, on comparing the detected adverse condition to predetermined safety level information.

9. The method of claim 8, further comprising performing one or more operations based on the determined severity level.

10. The method of claim 1, wherein the one or more signals are obtained using a glucose sensor comprising a plurality of electrodes including a working electrode, the working electrode comprising a glucose-responsive enzyme and a mediator, at least one of the glucose-responsive enzyme and the mediator chemically bonded to a polymer disposed on the working electrode, and at least one of the glucose-responsive enzyme and the mediator crosslinked with the polymer.

11. The method of claim 1, wherein the predetermined insulin dose safety level is a non-zero pre-programmed closed loop operation state to avoid over-dosing of insulin.

12. The method of claim 1, wherein the adjustment of the execution of the impending administration of the insulin to the predetermined insulin dose safety level is performed by reducing the insulin delivery rate by a factor to maintain the insulin delivery within the safety level.

13. A device, comprising:

one or more processors; and

a memory operatively coupled to the one or more processors, the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to monitor a plurality of parameters associated with a closed loop control operation including continuously monitoring a physiological condition and an automatic administration of insulin, detect an impending administration of the insulin exceeding a predetermined insulin dose threshold level, retrieve one or more signals associated with the monitored physiological condition in response to detecting that the impending administration of the insulin exceeds the predetermined insulin dose threshold level, determine an accuracy indication of the retrieved one or more signals associated with the monitored physiological condition, the accuracy indication associated with a false low glucose reading and based on a signal dropout condition or an early signal attenuation condition, automatically adjust execution of the impending administration of the insulin to a predetermined insulin dose safety level when the determined accuracy indication of the retrieved one or more signals associated with the monitored physiological condition exceeds a predetermined accuracy threshold level, and discontinue retrieving the one or more signals associated with the monitored physiological condition in response to detecting that the impending administration of the insulin exceeds the predetermined insulin dose threshold level when a predetermined consecutive number of the retrieved one or more signals associated with the monitored physiological condition are within the predetermined accuracy threshold;

wherein the adjustment to the execution of the impending administration of the insulin to the predetermined insulin dose safety level is made, and receipt of the one or more signals associated with the monitored physiological condition are discontinued, upon determining the accuracy indication is associated with a false low glucose reading and is based on a signal dropout condition or an early signal attenuation condition.

14. The device of claim 13, wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to determine the retrieved one or more signals associated with the monitored physiological condition outside of a predetermined accuracy acceptable range, and generate a request command to enter a current blood glucose value.

15. The device of claim 13, wherein the monitored physiological condition is associated with a glycemic level of a person.

16. The device of claim 13, wherein the continuously monitored physiological condition includes analyte levels.

17. The device of claim 13, wherein when the accuracy indication indicates an unacceptable level of accuracy associated with the retrieved one or more signals, the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to modify the closed loop control operation to perform one or more of requesting an additional blood glucose measurement value, disabling the closed loop control operation and initiating a semi-closed loop control or manual control operation, or performing recalibration of the retrieved one or more signals.

18. The device of claim 13, wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to receive a blood glucose measurement, and analyze the retrieved one or more signals associated with the monitored physiological condition based on the received blood glucose measurement.

19. The device of claim 18, wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to calibrate the one or more signals with the received blood glucose measurement.

20. The device of claim 13, including a strip port to receive a blood glucose test strip including a blood sample, wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to determine a blood glucose value based on the blood sample.

21. The device of claim 20, wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to correlate the retrieved one or more signals associated with the monitored physiological condition based on the determined blood glucose value.

22. The device of claim 21, wherein the accuracy indication is based, at least in part on the correlation.

23. The device of claim 13, wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to store data describing an amount of the executed administration of the insulin.

24. The device of claim 13, wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to detect an adverse condition associated with the operation of the device and determine a severity level of the detected adverse condition based, at least in part, on comparing the detected adverse condition to predetermined safety level information.

25. The device of claim 24, wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to perform one or more operations based on the determined severity level.

26. The device of claim 13, wherein the one or more signals are obtained using a glucose sensor comprising a plurality of electrodes including a working electrode, the working electrode comprising a glucose-responsive enzyme and a mediator, at least one of the glucose-responsive enzyme and the mediator chemically bonded to a polymer disposed on the working electrode, and at least one of the glucose-responsive enzyme and the mediator crosslinked with the polymer.